GRU dog experiment sound, researcher says

The head of research for Georgia Regents University’s dental school said he is not aware of any upcoming dental implant testing on dogs, but documents obtained by The Augusta Chronicle show the school sought and received approval in June to continue experiments for another three years.

The Humane Society of the United States alleged in November that the experiments conducted on six dogs in March, witnessed by an undercover investigator, were frivolous and driven by profit.

According to a research protocol obtained by The Chronicle, researchers were attempting to develop an antimicrobial coating that would prevent infection from colonizing dental implants, an issue that arises in about 10 percent of cases.

Dr. Christopher Cutler, the chairman of the Department of Periodontics at GRU and interim associate dean for research at the dental school, said this is a pioneering approach to solving a serious medical issue and had to be tested in animals before human clinical trials could begin.

The research protocol for this experiment was first approved in 2010 by the Institutional Animal Care and Use Committee, a group of faculty and community members required by federal law to approve all animal testing. The protocol was renewed for another three years in June, three months after the experiment witnessed by the Humane Society, internal memos obtained by The Chronicle show.

Cutler declined to say how many times the experiment had been performed on dogs since 2010.

Cutler said the IACUC is charged with screening all studies to “make sure that these animals are not subjected to this therapy in vain.” The members have the opportunity to pose questions to researchers and get more information before approving a protocol.

The newspaper obtained a copy of the minutes to the IACUC’s 2010 and 2013 meetings where these experiments were approved, but the university redacted almost every word, making it impossible to tell whether this discussion between the IACUC and researchers took place.

GRU officials have not determined how they will address another concern raised by the Humane Society – the fact that the school purchases animals from Class B dealers. These dealers obtain animals from sources such as shelters, “free to good home” ads and strays, and sell them to labs. Class A dealers breed animals purposely for research.

The National Institutes of Health, the largest source of public funding in the U.S., will discontinue funding projects that use animals from Class B dealers in 2015.

Cutler and Senior Vice President for Research Mark Hamrick said university officials are discussing this issue and will decide how to proceed “soon.”

IN THE DENTAL EXPERIMENT conducted on dogs in March, implants with the antimicrobial coating were to be placed in six hound dogs along with an already approved implant for comparison. Eight weeks after the surgery, the dogs were euthanized so the implants could be examined. Dogs are used because their jaw sizes and teeth allow for a better comparison to humans, and the type of disease and bone loss they experience is very similar to what humans would experience, Cutler said.

“I think it is fair to say that we would welcome in the future a better model for use in less sentient animals,” he said. “I think everyone would like to get completely away from animal research, but it is so important to medical research. Every major breakthrough in terms of medical devices, in terms of cancer drugs, has first been tested in animals becauseof the complexity of the biological systems.”

Cutler said researchers across the world are trying to develop such a technology that will prevent infection and acknowledged there is a commercial gain to be made.

This particular experiment was privately rather than publicly funded, but school officials were not willing to disclose the source.

“You think about every major medical advancement in either medical devices or pharmaceuticals, there has to be support behind it, financial support with the understanding that some ultimately is going to the shareholders,” Cutler said.

However, he said the main goal was to prevent implants from infection and failure. He said that while most people think of implants as cosmetic, they serve an important functional purpose – without teeth for chewing hard, fibrous foods, diet is limited to soft foods, which can lead to nutritional deficiencies and digestive problems.

Any infection in the mouth can also turn invasive and enter the bloodstream, attaching to heart lining or valves and cause a serious infection called endocarditis.

A meta-analysis published last month in the Journal of Periodontology found that less serious infections occur 63 percent of the time with implants and a more serious peri-implantitis occurs with 9.6 percent of implants.

Cutler said the next step for his researchers would be to seek approval so clinical trials in humans could begin, but he did not know whether that process had begun. He could not disclose where the researchers were in the process but said he wasn’t aware of any additional tests.

“I am sure that at other institutions, not only in the United States but worldwide, there are ongoing research projects that are testing these antimicrobial coatings. But to my knowledge this is not an ongoing project here,” he said.

USDA INVESTIGATION

The U.S. Department of Agriculture, the federal agency responsible for enforcing the Animal Welfare Act, inspected the lab animal facility at GRU Dec. 17-19 in response to allegations from the Humane Society of the United States.

The USDA will not release its findings until January, but GRU released a statement Thursday with the findings.

According to GRU, USDA inspectors found “no evidence that animal procedures had been performed without approval.” The agency identified the following concerns:

• Specific social housing exemptions for non-human primates need to be provided for each animal by the attending veterinarian, and enrichment provided.

• The animal use protocol governing dental research in dogs should include a search for alternative procedures to “dental extraction” in addition to already-conducted searches for alternatives to animal research.

• Two expired medical solutions were identified in the animal facility.

• Hamster cages need to be cleaned more often.

• There was excessive dust surrounding an air vent and light fixture located above an animal enclosure, and one wall in an animal area had food debris.

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I guess if someone who is obviously vested in the research outcome, $, says it is ok and is necessary, then that's it. Where they get the animals, and what they do to them, is of no consequence. The article says there are Class A animals bred for research. Sounds like it's then ok to use them and euthanize them if they are just bred for experiments. Humans have a long way to go before we can say we are civilized.

The larger point is being missed here. Over 90 percent of the allegations by the Humane Society of the United States were not verifiable by the USDA inspectors. The HSUS wasted an enormous amount of time, resources, and money, both theirs and the taxpayers, and the Chronicle spent a lot of its front page coverage on these false allegations. Hundreds of phone calls and emails were sent to the researchers and administration of GRU over these issues, and those people were intentionally misled. A lot of damage was done because the Humane Society wants to run a campaign against the use of Class B dogs in biomedical research, and they don't care who gets hurt as long as they continue to solicit donations.

A large number of taxpayers are still upset & disgusted with GRU for using hound dogs for their dental implant experiments. The HSUS inspection was warranted & GRU will need to be continually inspected. GRU's management & approving body made giant missteps deciding to use dogs - which are human's constant & most desired companion animals. Taxpayer funds were involved in these experiments - even if a GRU housekeeping employee emptied trash cans, if GRU computers were used, if a lease was not paid by the private party that promoted these experiments, ...GRU letterhead, staples, paper clips, etc. The GRU officials that approved these experiments should be reprimanded. They failed. An experiment is not complete without studying the aftercare of the patient. You NEVER should have cut off those dogs jaws and euthanized them! In the future - YOU need to consider the social outrage of people before approving any animal experiments!

and any discussion that doesn't acknowledge that people
would be harmed without the data gained from the experiments
is incomplete and disrespectful
for the humane society to claim that these experiments are
"frivolous and driven by profit" is disrespectful to the doctors and the patients
and the animals involved
"frivolous and driven by profit" involves no dilemma
"frivolous and driven by profit" is easy to oppose
"frivolous and driven by profit" casts the doctors as evil
"frivolous and driven by profit" ignores the benefits of the research
"frivolous and driven by profit" is a lie
the researchers involved wrote an article that truthfully acknowledged the dilemma
and their own difficulty in doing the research
they know well both sides of the situation and they respected both sides
so should everyone else

The USDA and other groups inspect GRU, and any other university performing animal research, REGULARLY. This was a special investigation in response to the HSUS allegations, which have been proven false.
If you are so against animal research, please refuse all treatment next time you go see your doctor. Also, please stop wearing makeup and washing your hair, for that matter.

on animals for personal hygiene, so I'll still be washing my hair. I come from a family with several Medical Doctors and other medical professionals - and none of them are interested in having dental implants. All were disgusted with GRU's decision to use hound dogs.

Why argue with an ignorant rock? I just gave thumbs up for those who aren't delusional and thumbs down for you who refuse to admit you have a mental problem and equate dogs to humans. Ignorance truly is blind.

I truly hope that you and your family full of medical doctors never have head and neck cancer or any other disease that deteriorates your jawbone and causes your teeth to fall out. If you do, please refuse the implants.

Well I a lot of family members who are physicians and dentists too and because they are well educated they support research that will lead to cures to save human lives as their hippocratic oath mandates-it only applies to humans.

Personally I'd sacrifice hundreds if not thousands of dogs to save but one human life. When you think about how the future of embryonic stem cells was dependent on human bastocysts the sacrifice of a dog seems like an easy choice. The next transplanted tissue you may receive may be from "sterile" hogs that will not illicit an immune response,sutures made from animal products, heart valve replacement from animal, gelatin in capsule made from animal, etc. "The World Health Organization (WHO) estimates that as many as 80% of the world's more than six billion people rely primarily on animal and plant-based medicines. The healing of human ailments by using therapeutics based on medicines obtained from animals or ultimately derived from them is known as zootherapy. The phenomenon of zootherapy is marked both by a broad geographical distribution and very deep historical origins."

Chicken-manure thumbs downs because you don't have a logical cogent argument. Just my dog is a person-which is delusional.
Here is a quote from the Humanist.org:
"There was a time when "Dog is my co-pilot" was merely a fun slap at the "God is my co-pilot" bumper sticker, and it was funny precisely because nobody would ever think to elevate their dog to such a height. Within the past decade, however, pets—primarily dogs—have soared in importance. ("Dog is my co-pilot" is now the slogan of Bark, a magazine of dog culture, and the title of an anthology—published by Bark's editors—billed as essays, short stories, and expert commentaries that explore "every aspect of our life with dogs.") Canines, with their pack instincts and trainability, are by far the most likely pet to be anthropomorphized as a family member, a best friend, or a "fur baby," treated accordingly with gourmet meals, designer apparel, orthopedic beds, expensive therapy, and catered birthday parties. Some people even feel (and in some cases, demonstrate) that their dogs are worth dying for. Others say the animal lovers are going too far.

In a Pew Research Center study, 85 percent of dog owners said they consider their pet to be a member of their family. However the latest trend is to take that a step further in seeing the animal as a child. A company that sells pet health insurance policies has dubbed the last Sunday in April is "Pet Parents Day." Glance through magazines like Bark, Cesar's Way (courtesy of "Dog Whisperer" Cesar Millan), and other mainstream publications, and the term "pet parent" crops up regularly. The "my-dogs-are-my-kids" crowd isn't being tongue-in-cheek, either. They act on their beliefs, buying Christmas presents, photos with Santa, cosmetic surgery, and whatever-it-takes medical care for their animal. In fact having a puppy, claimed one "mother," is "exactly the same in all ways as having a baby." And while pushing a dog around in a stroller would have gotten you directions to a mental health facility twenty years ago, today it's de rigeur to see a canine in a stroller (or a papoose), and some passersby are downright disappointed to discover a human infant inside."

I'm curious if individuals who are posting comments critical of the Human Society are at all concerned about the use of Class B animals in research (which is something the NIH will not be funding). I'm also curious if these same individuals have any concern about GRU redacting the information requested by the Augusta Chronicle. It seems that most of the comments so far are focused on the issue of how people compare animals/dogs to humans; in doing so it seems that perhaps other significant issues are being ignored.

The Humane Society of the United States alleged in November that the experiments conducted on six dogs in March, witnessed by an undercover investigator, were frivolous and driven by profit.

Frivolous is in the eye of the beholder. If your jaw became infected after receiving one of those early implants (FDA approved, by the way), then you would likely be very supportive of new research using dogs to design a better implant that would fight infection. Just ask James Brown.

Driven by profit, you scorn - - - well, practically all of human progress was driven by profit. Profit earned by free enterprise is better than plunder under government coercion.

They redacted it likely the same reason our govt redacts documents-because some text is personal, irrelevant, or illegal to publish. It was funded by private funds-likely some benevolent local society (Eagles, Masons, etc ). They don't want to be attacked by animal nut jobs for trying to do good or honor some dying members wish was to fund some research.

You asked about redacted statements. No mention of NIH using Class B vendors in my statement. Have a difficult time staying on topic? Since NIH didn't fund this, but private, they used Class B animal vendors to save money I guess. What difference does it make since the FDA has investigated the Humane society accusations and found them mostly baseless except some minor infractions-like you see at local restaurants.

]
Class A breeders are licensed by the U.S. Department of Agriculture (USDA) to sell animals bred specifically for research. In July 2004, there were 4,117 licensed Class A dealers in the United States.
Gee that isn't a lot considering they are a major source of animals for research?
Class B dealers are licensed by the USDA to buy animals from "random sources." This refers to animals who were not purpose-bred or raised on the dealers' property. Animals from "random sources" come from auctions, pounds, newspaper ads (including "free-to-home" ads), and some may be stolen pets or illegally trapped strays.[ As of February 2013, there were only seven active Class B dealers remaining in the United States. However, these sources round up "thousands" of cats and dogs each year for sale.
So only 7 Class B dealers. Gee.
NIH prefers Class A because the possibility of introducing disease to stocks or unknown problems with uncharacterized dogs.

Horton, under Georgia Law, items may be redacted if they lead to personally identifiable information (or trade secrets). In cases like this, personnel at GRU are actively harassed for months via email and phone calls (cell phones and home phones at all hours) as a result of the actions of the Humane Society of the United States. It is regrettable that this harassment prevents further transparency in this process, but rest assured that the USDA and NIH do not see redacted documents when they perform inspections.

The debate over the use of animals is NOT fought by harassing academic personnel. It is debated by veterinarians, researchers, laypeople, and legislators in well-defined forums. Its regulations are enforced by twice yearly inspections from outside agencies. The Humane Society is not comfortable with the current state of law, so they attempt to circumvent it like a 5 year old who cannot get his way by following the rules. In this case they made enormous errors in judgment in alleging infractions that were in fact in line with current regulations. In so doing, they wasted everyone's time, and a lot of money, both theirs, the taxpayers', and the Chronicle's.

Walter, thanks for your comments. I understand your point of view and agree; my questions and comments were not intended to imply that I support actions by any group that harasses academic personnel. Nor do I necessarily believe animals are mistreated at GRU. Nor do I believe the research is necessarily frivolous. However, I remain concerned that GRU was using a Class B vendor who was under investigation; as well as the NIH position on the use of Class B vendors. GRU has done little to instill confidence in its dealings; whether the entire document actually required redacting to preserve valid confidential information is not something I completely believe. This is after all, the same organization that has misled the community on several other issues, such as the naming process. It matters little me whether they spent 45 cents or 45 thousand dollars on a survey, the misrepresentation of how the name was really going to be handled is the disappointing part. Unfortunately, at this point I have little trust in what GRU publishes.

Horton, GRU released preliminary findings of the USDA report. The USDA report IS an open document, and will likely be sent without a FOIA request to the Humane Society in response to their "whistleblowing". This is not a case of things being hidden from everyone. Responsible parties are actually conducting an investigation and issuing an open report. GRU, apparently, wanted their version of the report released immediately (USDA left on Thursday). My take on this is that GRU wanted the public to know as quickly as possible that the Humane Society's allegations were largely false.

For Class B vendors, you should understand a few things. The big hangup is that, by and large, the parties that make the rules have decided that an animal that MIGHT have EVER been someone's pet should not be used in biomedical research, even if it is to be euthanized anyway. That is the prevailing judgment from laypeople, legislators, researchers, and veterinarians. Class B vendors source animals from shelters, auctions, and breeding "unwanted" animals. If an animal with no id shows up at a shelter, it can be used as a Class B animal. The precautions are not really in place to ensure that no animal that was ever a pet could become a research animal (even though legally they cannot). As a result, NIH is phasing the Class B vendors out in another year. A Class B dog is about one fifth the price of a Class A dog. ALL Class B dogs would be euthanized if not used in research.

It is not illegal to use Class B animals, and all of them are leftovers headed for euthanasia. Now, virtually all animal suppliers, both Class A and Class B suppliers, have existing citations from the USDA, as does every research facility in America (including GRU). You really need to read the actual citations to understand how bad they were for animal welfare. I read his citation, and it is unclear to me how bad it is for the animals. He will need to correct these citations, or he will lose his license and be fined a substantial amount (yes, the system does actually work that way). He does not need the Humane Society breathing down his back with their open harassment. He already has the USDA doing it.

That's what this really comes down to. The Humane Society wants to harass people involved in Class B use of animals, particularly dogs. By making public Kenneth Schroeder's contact information, the Humane Society has facilitated thousands upon thousands of phone calls to someone who runs a legal business that is already being regulated by the relevant authorities. That's how animal rights works. If we don't agree with the law, we harass everyone involved to try to allow us to define the law. Even if we are in the vast minority.

You should be outraged at someone, but I suspect it is the wrong party.

Walter, I'm not outraged; only concerned and unconvinced there is no issue here. I agree and understand that it is not illegal to use animals from Class B vendors. However, since Class B animals are not bred for research there is a potential that research outcomes are skewed as a result; in other words use of such animals introduces another variable that might not be controllable which then may muddy the research outcome. Perhaps this is another reason why NIH is discontinuing their funding of studies that use Class B. GRU (like many institutions) wants the public to believe that only top notch research conducted by top researcher ever occurs. That really can't be the case when Class B animals are used. Sometimes the cost savings really don't pan out to be a real savings if the research results can't be trusted because of the quality of sources used in the process. Even if the dental implant study was not funded by NIH, the interesting part of this whole story to me is that GRU has used Class B. Even though it is legal to use Class B animals that does not necessarily equate 100% to it being a wise choice (or ultimately cost saving choice).

I'm not an animal activist and I'm not worried animals being euthanized; and I don't support the type of extreme activity that is associated with extremists; however I also don't yet buy that GRU is a totally innocent victim in this scenario.

The choice to use Class B or Class A animals really depends on the research. For the types of research done with dogs, it is almost impossible to conceive that Class A or Class B would make a difference. When it gets down to the details and molecular pathways are being studied, the research invariably is switched to a rodent model (mouse) in which the genetic background is much more well defined, and much larger numbers of animals are required to satisfy statistical criteria.

No animal research facility is totally clean. There are rules and mechanisms in place to enforce them. There are failures to follow rules, and failures to enforce regulations, and citations, and fines. It's not really very different from anything else in society that is regulated. However, the dog studies highlighted in this account are among the cleanest around. FDA "required testing" was being done in a preclinical product. Dogs received outstanding veterinary care, and anesthesia and analgesia management. The USDA specifically investigated these specific experiments and found no fault (and they are, by definition, fault finders). The Humane Society screwed up.

Reports published by NIH do not support the view suggested by Walter; see for example the excerpt below that was included in one its reports on the topic of Class B:

"In summary, based on the limited available evidence, random source dogs and cats used for research probably endure greater degrees of stress and distress compared to purpose-bred animals. This conclusion has implications both for the welfare of random source animals and for their reliability as research models. Stress and distress are known to significantly alter animals’ physiological and behavioral responses to experimental manipulations, and will therefore affect the quality of the scientific results obtained from such animals (NRC 2008; Reinhardt 2004)."

For the full NIH commentary/book on the topic, readers may be interested in the NIH publication entitled: "Scientific and Humane Issues in the Use of Random Source Dogs and Cats in Research."
It can be found by visiting the NIH homepage and doing a search on Class B.

If you read the above report, you will see that it specifically recognizes the value of random source dogs and cats in biomedical research. However, resources for enforcement of animal welfare standards for animals WHILE AT THE CLASS B DEALER are lacking, and there is evidence that they are not held to the same standards as the animals are ONCE THEY ARE DELIVERED TO THE RESEARCHERS. Again, this is the case of the Humane Society targeting GRU because they want to expedite the demise of Class B dealers. They, and others, find fault in the existence of Class B dealers, and want to shame people associated with them. And, again, the USDA inspection found no fault in these or any other dog studies conducted at GRU.

The report also notes that random source animals can come from Class A dealers, as well, without the same sorts of problems. Random source animals have more varied genetic backgrounds than purpose bred animals, and in some types of studies this background is more desireable. You can get into a niche where you make biomedical discoveries that are dependent on the strain of animal you are looking at, and those usually are not as valuable.